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Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes

NCT05200390 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-05-04

No results posted yet for this study

Summary

The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM).

The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.

Conditions

Interventions

DEVICE

Continuous glucose monitor

FreeStyle Libre 2 system

Sponsors & Collaborators

  • St. John Fisher College

    collaborator UNKNOWN

  • Chieh Chen

    lead OTHER

Principal Investigators

  • Elizabeth Phillips, PharmD, CACP · St. John Fisher College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2022-11-30
Completion
2023-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200390 on ClinicalTrials.gov